BREAKING—holy crap—Trump WH is now blocking the FDA proposed guidelines for the emergency release of a coronavirus vaccine. Basically WH has vetoed tougher safety/efficacy standards for a vaccine! #COVID19 🧵 (repost) nytimes.com/2020/10/05/us/…
2) Essentially, FDA had inserted a vaccine minimum efficacy standards that would have almost certainly guaranteed that no vaccine could be authorized before the election on Nov. 3... but now Trump WH has now OVERRULED & BLOCKED it. Thereby Trump HHS now has no such restrictions.
3) “The conflict began almost as soon as the Food and Drug Administration submitted the guidelines to the White House budget office on Monday, Sept. 21. The next day, Dr. Stephen M. Hahn, the F.D.A. commissioner, briefed Mr. Azar on the matter.”
4)“Mr. Meadows raised a series of concerns. He questioned the need for 2 months of follow-up data, said that stricter recommendations would change the rules in the middle of clinical trials and suggested that Dr. Hahn was ***overly influenced by his agency’s career scientists***
5) “Facing a White House blockade, FDA is seeking other avenues to ensure vaccines meet the guidelines. That includes...an outside advisory committee of experts...The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.”
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